Key Players in Medical Device Regulation: Economic Operators under EU MDR and IVDR


- 3 days ago
- 3 min
Navigating Regulatory Gray Areas: Borderline Devices in the EU MDR and IVDR Era

- 4 days ago
- 3 min
Class I Medical Devices and CE Marking: Compliance Essentials


- 5 days ago
- 5 min
Navigating the Complex World of Combination Products: Understanding EU MDR Article 117


- 6 days ago
- 4 min
Certifying Medical Devices in the EU: The Crucial Role of Notified Bodies under MDR and IVDR

- 7 days ago
- 4 min
The CE Mark is Just the Beginning: Post-CE Compliance under EU MDR

- Sep 25
- 4 min
EU MDR Compliance: Navigating the Essential EUDAMED Modules

- Sep 24
- 6 min
Deciphering Medical Device Risk Classification Under EU MDR

- Sep 23
- 5 min
Navigating the EU MDR Labelling Requirements: A Comprehensive Guide

- Sep 22
- 4 min
Regulation of Reusable Medical Devices under EU MDR

- Sep 21
- 7 min
Understanding System and Procedure Packs in Accordance with EU MDR

- Sep 18
- 4 min
Understanding the CE Marking Process for Medical Devices in the EU

- Sep 17
- 8 min
Regulation of Reprocessed Single-Use Devices (SUD) under EU MDR

- Sep 16
- 4 min
Essential Considerations for Reprocessing Single-Use Devices in Accordance with EU MDR


- Sep 15
- 4 min
Conformity Assessment of Medical Devices under EU MDR


- Sep 9
- 2 min
UK Responsible Person (UKRP): Obligations for Medical Device Manufacturers Outside the UK


- Sep 8
- 4 min
Navigating Switzerland's Medical Device Regulations: The Role of Swiss Authorized Representatives


- Sep 6
- 4 min
Meeting EU Regulations: The Role of the European Authorized Representative (EAR)

- Aug 28
- 5 min
Biologics and Biosimilar Regulations and Registration in the European Union (EU) (EMA)


- Aug 1
- 7 min
Pharmaceutical Regulations in European Union